510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K946080Substantially Equivalent

Physio Control Lifepak 200 Auto Defibrillator

Portable Power Systems, Inc., Castle Rock CO / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K946080 is the FDA 510(k) clearance record for PHYSIO CONTROL LIFEPAK 200 AUTO DEFIBRILLATOR, a class I device, cleared for Portable Power Systems, Inc. on under FDA product code FCO (Box, Battery, Rechargeable). FDA records list 18 510(k) clearances for Portable Power Systems, Inc., from to . As of , FDA records show no recalls naming K946080.

Clearance record

Decision date
Received
(232 days to decision)
Product code
FCO Box, Battery, Rechargeable
Regulation
21 CFR 876.1500
Device class
Class I
Review panel
Gastroenterology, Urology
Applicant
Portable Power Systems, Inc. 1940 Tee Ln., Castle Rock CO
510(k) summary
Statement
Third party review
No

Clearances, product code FCO

Trailing 12 months

FDA records hold no clearances under product code FCO in the trailing twelve months.

FDA records show no clearances under product code FCO in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code FCO, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260